USA – Pfizer has announced that Paxlovid, an investigational oral antiviral, reduced COVID-19-related hospitalizations and deaths by 89 percent in a phase 2/3 study of nonhospitalized adults at high risk for severe disease.
Pfizer said it would stop enrolling participants in the study and submit data to the FDA as part of an ongoing submission for emergency use authorization due to the “overwhelming efficacy” of the treatment.
The study focused on high-risk patients who had not yet been hospitalized, with an interim analysis based on 1,219 patients enrolled in sites around the world by late September.
According to the data, only 0.8% of study participants who took the antiviral pill within three days of developing symptoms were hospitalized, compared to 7% who received a placebo.
These results were comparable to those obtained after only five days of treatment. None of the patients who received Paxlovid died, whereas 1.6 percent of those who received a placebo died.
“These data suggest that our oral antiviral candidate, if approved or authorized by regulatory authorities, has the potential to save patients’ lives, reduce the severity of COVID-19 infections, and eliminate up to nine out of ten hospitalizations,” Pfizer CEO and chairman Albert Bourla said.
Both Pfizer and Merck’s antiviral medications work by interfering with the coronavirus’s ability to replicate itself.
Pfizer claims that co-administering a low dose of ritonavir, a drug used in HIV/AIDS treatment regimens, also helps its pill. Ritonavir prolongs the half-life of protease inhibitors like the Pfizer drug, making them more effective in fighting viruses.
Officials in both the United States and the United Kingdom believe that effective COVID-19 pills, which can be administered at home, could be a game changer in the fight to end the pandemic.
Regeneron’s antibody cocktail has become a critical tool in medical workers’ rush to prevent the worst outcomes for COVID-19 patients, but the monoclonal antibody treatment requires either an intravenous infusion or a series of shots.
According to Pfizer, its drug could be prescribed to reduce the severity of COVID-19 patients’ illnesses as well as the likelihood of adults becoming infected after being exposed to the coronavirus.
The results of the study suggest that the drug is even more effective than Merck’s antiviral pill, which cuts the risk of hospitalization and death by half, even though the trial results may not be directly comparable.
Merck’s oral antiviral drug has received its first authorization in the United Kingdom.
The trial results have heightened the hopes that the world will soon have access to enough vaccines and drugs to end the pandemic that has ravaged that global economy and claimed more than 5 million lives worldwide.
Scott Gottlieb, a Pfizer board director and former head of the US Food and Drug Administration said: “We have an overwhelming therapeutic toolbox to eliminate death and suffering from Covid.”